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- Shortages and supply disruptions (15)
- Safety monitoring and information (10)
- Manufacturing (7)
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- Import and export (3)
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Collection content
109 result(s) found, displaying 11 to 20
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PageInformation about progressive discontinuation of Benpen injection products
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PageInformation about what to include in the Product Information (PI) and Consumer Medicine Information (CMI) for products included in the Black Triangle Scheme.
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PageInformation for applicants on requesting and preparing for pre-submission meetings for medicines and biologicals.
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GuidanceGuidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
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PageInformation for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines.
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PageFind out about obtaining Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site.
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PageInformation on proposing a new ingredient name to be included on the approved list.
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PageGLP-1 receptor agonists such as Ozempic (semaglutide) and its derivatives are regulated as prescription-only medicines.
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PageApplications for extension of indications to align with a reference product can be submitted via the Variation e-form. This electronic form is available through the TBS portal.